Introduction
Materials and methods
Patients
Study design
Assessments and outcome measures
Statistical analysis
Results
Patients and treatment
Efficacy
Subgroup | CT-P6 (N = 271) | Trastuzumab (N = 278) | Estimated treatment difference (95% CI) |
---|---|---|---|
Age | |||
pCR | |||
≥ 65 years | 14/31 (45.2%; 27.3–64.0) | 20/40 (50.0%; 33.8–66.2) | − 0.05 (− 0.28 to 0.19) |
< 65 years | 104/240 (43.3%; 37.0–49.9) | 111/238 (46.6%; 40.2–53.2) | − 0.03 (− 0.12 to 0.06) |
Breast pCR | |||
≥ 65 years | 17/31 (54.8%; 36.0–72.7) | 25/40 (62.5%; 45.8–77.3) | − 0.08 (− 0.31 to 0.16) |
< 65 years | 116/240 (48.3%; 41.9–54.9) | 120/238 (50.4%; 43.9–56.9) | − 0.02 (− 0.11 to 0.07) |
Region | |||
pCR | |||
EMEA | 92/209 (44.0%; 37.2–51.0) | 107/222 (48.2%; 41.5–55.0) | − 0.04 (− 0.14 to 0.05) |
Asia | 21/50 (42.0%; 28.2–56.8) | 19/46 (41.3%; 27.0–56.8) | 0.01 (− 0.19 to 0.21) |
America | 5/12 (41.7%; 15.2–72.3) | 5/10 (50.0%; 18.7–81.3) | − 0.08 (− 0.49 to 0.34) |
Breast pCR | |||
EMEA | 103/209 (49.3%; 42.3–56.3) | 119/222 (53.6%; 46.8–60.3) | − 0.04 (− 0.14 to 0.05) |
Asia | 23/50 (46.0%; 31.8–60.7) | 21/46 (45.7%; 30.9–61.0) | < 0.01 (− 0.20 to 0.21) |
America | 7/12 (58.3%; 27.7–84.8) | 5/10 (50.0%; 18.7–81.3) | 0.08 (− 0.34 to 0.49) |
Disease stagea | |||
pCR | |||
I | 13/23 (56.5%; 34.5–76.8) | 14/31 (45.2%; 27.3–64.0) | 0.11 (− 0.16 to 0.37) |
IIA | 31/75 (41.3%; 30.1–53.3) | 41/86 (47.7%; 36.8–58.7) | − 0.06 (− 0.22 to 0.09) |
IIB | 52/105 (49.5%; 39.6–59.5) | 56/98 (57.1%; 46.7–67.1) | − 0.08 (− 0.21 to 0.06) |
IIIA | 21/64 (32.8%; 21.6–45.7) | 19/61 (31.1%; 19.9–44.3) | 0.02 (− 0.16 to 0.19) |
Breast pCR | |||
I | 14/23 (60.9%; 38.5–80.3) | 14/31 (45.2%; 27.3–64.0) | 0.16 (− 0.12 to 0.41) |
IIA | 35/75 (46.7%; 35.1–58.6) | 44/86 (51.2%; 40.1–62.1) | − 0.05 (− 0.20 to 0.11) |
IIB | 55/105 (52.4%; 42.4–62.2) | 62/98 (63.3%; 52.9–72.8) | − 0.11 (− 0.24 to 0.03) |
IIIA | 28/64 (43.8%; 31.4–56.7) | 24/61 (39.3%; 27.1–52.7) | 0.04 (− 0.13 to 0.22) |
CT-P6 (N = 271) | Trastuzumab (N = 278) | |
---|---|---|
Patients with surgery, n (%) | 258 (95.2) | 261 (93.9) |
Patients with ≥ 1 RT, n (%) | 142 (55.0) | 131 (50.2) |
Breast only | 60 (23.3) | 60 (23.0) |
Breast + axilla only | 7 (2.7) | 15 (5.7) |
Breast + SCV/IMC/other ± axilla | 57 (22.1) | 48 (18.4) |
Breast + other ± axilla | 13 (5.0) | 9 (3.4) |
Breast + axilla + SCV ± other | 26 (10.1) | 20 (7.7) |
Breast + axilla + SCV + IMC ± other | 3 (1.2) | 3 (1.1) |
Breast + SCV + IMC ± other | 1 (0.4) | 2 (0.8) |
Othera | 18 (7.0) | 8 (3.1) |
Patients with ≥ 1 hormonal therapy, n (%) | 102 (39.5) | 99 (37.9) |
Anastrozole | 23 (8.9) | 20 (7.7) |
Exemestane | 0 | 2 (0.8) |
Letrozole | 17 (6.6) | 20 (7.7) |
Tamoxifenb | 63 (24.4) | 55 (21.1) |
Toremifene | 2 (0.8) | 1 (0.4) |
Goserelinb | 14 (5.4) | 9 (3.4) |
Leuprorelin acetate | 1 (0.4) | 1 (0.4) |
Safety
CT-P6 (N = 271) | Trastuzumab (N = 278) | |
---|---|---|
Overview of TEAEs | ||
Total number of TEAEs | 2880 | 3130 |
Patients experiencing ≥ 1 TEAEs | 263 (97.0) | 265 (95.3) |
Grade 1 or 2 | 158 (58.3) | 153 (55.0) |
Grade ≥ 3 | 105 (38.7) | 112 (40.3) |
Treatment relatedb | 129 (47.6) | 145 (52.2) |
Total number of treatment-emergent SAEs | 26 | 46 |
Patients experiencing ≥ 1 treatment-emergent SAEs | 20 (7.4) | 33 (11.9) |
Grade 1 or 2 | 3 (1.1) | 6 (2.2) |
Grade ≥ 3 | 17 (6.3) | 27 (9.7) |
Treatment related | 5 (1.8) | 8 (2.9) |
TEAEs leading to discontinuation | 11 (4.1) | 13 (4.7) |
TEAEs leading to death | 2 (0.7) | 2 (0.7) |
TEAEs of special interest | ||
Cardiac disorders | 30 (11.1) | 37 (13.3) |
Treatment related | 20 (7.4) | 24 (8.6) |
Infusion-related reactions | 31 (11.4) | 29 (10.4) |
Treatment related | 22 (8.1) | 18 (6.5) |
Treatment-related TEAEs reported in ≥ 5% of either treatment group | ||
Alanine aminotransferase increased | 4 (1.5) | 16 (5.8) |
Alopecia | 21 (7.7) | 25 (9.0) |
Anaemia | 11 (4.1) | 26 (9.4) |
Aspartate aminotransferase increased | 2 (0.7) | 15 (5.4) |
Asthenia | 24 (8.9) | 22 (7.9) |
Diarrhoea | 14 (5.2) | 12 (4.3) |
Ejection fraction decreased | 19 (7.0) | 9 (3.2) |
Infusion-related reaction | 22 (8.1) | 18 (6.5) |
Leukopenia | 7 (2.6) | 18 (6.5) |
Nausea | 15 (5.5) | 20 (7.2) |
Neutropenia | 19 (7.0) | 35 (12.6) |
Rash | 25 (9.2) | 11 (4.0) |